Blog Big Molecule Watch June 03, 2022

New BPCIA Complaint – Big Molecule Watch

Genentech filed a complaint yesterday against Tanvex in the U.S. District Court for the Southern District of California, alleging infringement of three patents under the BPCIA based on Tanvex’s submission of an aBLA for TX05, a proposed biosimilar of HERCEPTIN (trastuzumab).  Genentech asserts that Tanvex’s process for manufacturing TX05 infringes three patents:  U.S. Patent No. 10,662,237, generally directed to viral filtration methods, and U.S. Patent No. 10,808,037 and U.S. Patent No. 8,574,869, both of which are generally directed to methods to inhibit reduction of disulfide bonds by sparging pre-harvest or harvest cell culture fluid.  Genentech states in its complaint that the parties exchanged information under the BPCIA and agree upon the three patents to litigate.  Genentech seeks a declaration of infringement, and monetary damages in the event Tanvex imports, manufactures or launches TX05 in the United States before expiration of the asserted patents.

This is Genentech’s fifth BPCIA litigation against a trastuzumab biosimilar developer.  Genentech previously settled cases filed against Pfizer, Celltrion/Teva, Amgen, and Samsung Bioepis/Merck involving their respective trastuzumab biosimilars.  In 2017, Genentech also reached a settlement with Mylan in relation to Genentech’s patents for HERCEPTIN (trastuzumab), in which Mylan agreed to withdraw two IPR challenges.  Each company has commercially launched their trastuzumab biosimilars in the United States–Amgen launched KANJINTI (trastuzumab-anns) in July 2019, Mylan launched OGIVIRI (trastuzumab-dkst) in December 2019, Pfizer launched TRAZIMERA (trastuzumab-qyyp) in February 2020, Teva launched HERZUMA (trastuzumab-pkrb) in March 2020, and Samsung Bioepis launched ONTRUZANT (trastuzumab-dttb) in April 2020.

Stay tuned to Big Molecule Watch for developments on this new BPCIA case.

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